Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Blood Stem Cell Transplantation
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ClinicalTrials.gov Identifier: NCT00146614 |
Recruitment Status :
Completed
First Posted : September 7, 2005
Last Update Posted : March 8, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft Versus Host Disease Hematologic Malignancies | Drug: Sirolimus Drug: Tacrolimus Drug: Methotrexate Procedure: Stem Cell Transplantation | Phase 2 |
- Patients will be admitted to the hospital and receive chemotherapy and stem cell transplant(SCT). The total duration of hospitalization for the procedure is approximately 8 days. Once admitted the patient will receive fludarabine daily for 4 days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the patient will receive the infusion of donor cells.
- Just prior to the transplant and following the transplant, patients will receive sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy). Methotrexate will be given on days 1,3 and 6 after transplant.
- Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
- Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of GVHD and will be eliminated on week 26 if clinically feasible.
- Patients will also receive medication to help prevent possible infection.
- After stem cell infusion, patients will be examined and have blood tests weekly for 1 month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence of donor cells in the bone marrow. After the one month evaluation the patient will be examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 105 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation |
Study Start Date : | July 2002 |
Actual Primary Completion Date : | April 2003 |
Actual Study Completion Date : | April 2003 |

- To assess the effect on the incidence and severity of GVHD by adding sirolimus, tacrolimus and methotrexate to GVHD prophylaxis.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with hematologic malignancies who are at a high risk of complications after conventional transplantation.
- Donors (both related and unrelated) who are identical at 6 HLA loci.
- Age greater than 18
- ECOG Performance Status 0-2
- Life expectancy of greater than 100 days.
Exclusion Criteria:
- Pregnancy
- Evidence of HIV infection
- Heart failure uncontrolled by medications
- Total Bilirubin > 2.0mg/dl due to hepatocellular dysfunction
- AST > 90
- Serum creatinine > 2.0
- Cholesterol > 300 mg/dl

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146614
United States, Massachusetts | |
Beth Isreal Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Edwin P. Alyea, MD | Dana-Farber Cancer Institute |
Responsible Party: | Edwin P. Alyea, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00146614 |
Other Study ID Numbers: |
02-057 |
First Posted: | September 7, 2005 Key Record Dates |
Last Update Posted: | March 8, 2012 |
Last Verified: | March 2012 |
Graft versus Host Disease GVHD Stem Cell Transplantation Tacrolimus |
Sirolimus Methotrexate allogeneic stem cell transplantation |
Hematologic Neoplasms Graft vs Host Disease Neoplasms Immune System Diseases Neoplasms by Site Hematologic Diseases Sirolimus Methotrexate Tacrolimus Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Calcineurin Inhibitors Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |